ATTUNE 2545-00-524Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE RETAINING SIZE 4 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ATTUNE knee articulating surface is a trial instrument used during knee replacement surgery. The reports mostly describe the small spring coil on the instrument's post coming loose or falling off during surgery, along with parts of the instrument breaking, going missing, or bending. There are 85 reports, with no deaths and no injuries. One recall, now closed, started in June 2015 because that spring coil could become damaged and separate during trialing, potentially entering the surgical site.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 85
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10603295132646), received between Jul 24, 2017 and Aug 26, 2026 — classified as 85 malfunctions.
The most frequently reported specific device problem is “Break” (45 reports).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Jun 12, 2015Class IITerminated
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Z-2138-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break45
- Detachment of Device or Device Component28
- Component Missing9
- Material Deformation8
- Use of Device Problem4
- Material Twisted/Bent3
- Loose or Intermittent Connection2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- No Consequences Or Impact To Patient22
- Insufficient Information5
- No Information3
- Not Applicable2
- No Code Available1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453832 ↗MalfunctionJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE A COUPLE OF LOST SPRINGS FROM ARTICULATING SURFACES IN AN ATTUNE KIT DURING SURGERIES. IT WAS ALSO NOTED THAT THE IM REAMER HAD A NOT SHARP TIP. NO IMPACT ON PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414332 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTUNE FB CR ARTIC SURF SZ4 TRIAL DEVICE BROKE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209254 ↗MalfunctionDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BITS WERE BROKEN. IT WAS FURTHER REPORTED THAT THE SPRING WENT OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23846239 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIBIAL DEVICE BROKE DURING KNEE SURGERY. THE SPRING CAME OFF THE ARTICULATING SURFACE AND NEEDS REPLACING. NOTHING WAS LEFT INSIDE THE PATIENT, THE INSTRUMENT DID NOT BREAK IN TWO (THE SPRING CAME OFF), IT DID NOT DELAY THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658731 ↗MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE INSTRUMENTS WERE MISSING SPRINGS, AND EASILY DISPLACED FROM THE ARCTIC SURFS. BROKEN INSTRUMENTS, HAPPENED DURING SURGERY BUT NO PATIENT AFFECTED, OR SURGERY DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496035 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS SPANNED OFF OF THE ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23489871 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS FELL OFF IN COUPLE OF PROCEDURES. (B)(4), IS RELATED TO (B)(4) AND (B)(4). (B)(4), IS THE MOTHER COMPLAINT. (B)(4), AND (B)(4), WERE CREATED TO CAPTURE THE ADDITIONAL IPS OF THE MOTHER COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485750 ↗MalfunctionOct 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT SSD NOTED THAT THE THE SPRING WAS MISSING ON THE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392393 ↗MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ITEM WAS FOUND TO HAVE THE SPRINGS MISSING BEFORE THE CASE. THERE WAS NO RISK OF THEM BEING NEAR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030535 ↗MalfunctionSep 2, 2025Break; Break
IT WAS REPORTED THAT THE ITEMS WERE BROKEN ON AN UNKNOWN DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22939819 ↗MalfunctionJul 30, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED DURING THE PROCEDURE, THE METAL SPRINGS FROM THE UNDERSIDE OF THE ARTICULATING SURFACE HAVE BECOME DETACHED/FALLEN OFF. THE SPRINGS ARE MISSHAPEN AND STRETCHED AND SO CANNOT BE REATTACHED SECURELY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22664179 ↗MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. THE SPRINGS WERE NOT ATTACHED ANYMORE. ISSUE OCCURRED DURING SURGERY, BUT THERE WERE NO ISSUES AS THE SURGICAL TEAM MANAGED TO TAKE THE SPRING OUT. THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460425 ↗MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY. THE SPRING CAME OFF THE BACK OF THE ARTICULATING SURFACE, IT DID NOT BREAK IN HALF, NOTHING WAS LEFT INSIDE THE PATIENT AND IT DID NOT DELAY SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22161931 ↗MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE BELOW INSTRUMENT BROKE DURING KNEE SURGERY THIS MORNING AT HOSPITAL. IT IS MISSING ONE OF ITS SPRINGS, THERE WERE NO DELAYS TO SURGERY, NOTHING WAS LEFT INSIDE THE PATIENT. THE MISSING SPRING WAS NOTED ON OPENING THE INSTRUMENT TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969549 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. THE ATTUNE ARTICULAR SURFACE TRIAL HAD A CHIPPED TAB. NO AFFECT ON PATIENT. NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881539 ↗MalfunctionFeb 20, 2025Break; Break
IT WAS REPORTED THAT BAL SPRINGS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21426919 ↗MalfunctionDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2024, A PINNACLE INSTRUMENT WAS BROKEN. ALSO, AN ATTUNE ARTICULATE SURFACE WAS MISSING A SPRING. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037120 ↗MalfunctionDec 12, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. THE BREAKAGE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20918693 ↗MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO PATIENT HARM AND NO DELAYS TO SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20353086 ↗MalfunctionAug 22, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE IS A SPRING MISSING FROM THE ATTUNE ARTICULATING SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20030090 ↗MalfunctionJul 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING WAS MISSING FROM THE ARTICULATING SURFACE SO THE SHIMS ARE NOT SNAPPING TOGETHER PROPERLY. THERE WAS NO DELAY IN SURGERY AND NO NEGATIVE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19764853 ↗MalfunctionJul 11, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE METAL SPRING AROUND THE PEG GOT SNAPPED AND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720670 ↗MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE INSTRUMENT BROKE DURING KNEE SURGERY AT HOSPITAL. NO TIME WAS ADDED TO THE CASE, NO ADVERSE EVENTS WERE CAUSED TO THE PATIENT. THE SPRING CAME OFF THE ARTICULATING SURFACE, NO PARTS WERE LEFT IN THE PATIENT. IT DID NOT DELAY THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19458740 ↗MalfunctionMay 1, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
THE ARTICULATING SURFACE TRIAL PEG AND SPRING WERE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226478 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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